Stool Softener Docusate Sodium

Stool Softener Docusate Sodium
SPL v6
SPL
SPL Set ID 9d22d642-8aed-d17e-e053-2995a90ae182
Route
ORAL
Published
Effective Date 2020-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Water

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-24
Description

Docusate sodium 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Warnings

Directions
  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
 adults and children 12 years of age and older  take 1 to 3  softgels daily
 children 2 to under 12 years of age  take 1 softgel daily
 children under 2 years  ask a doctor

Do Not Use
  • if you are presently taking mineral oil, unless told to do so by a doctor
Questions?

call toll-free 1-800-935-6737

Other Information
  • ach softgel contains: sodium 7mg 
  • store at 15° to 30°C (59° to 86°F)
  • protect from moisture
Package Labeling:

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain 
  • nausea 
  • vomiting 
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener

Warnings

Directions
  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
 adults and children 12 years of age and older  take 1 to 3  softgels daily
 children 2 to under 12 years of age  take 1 softgel daily
 children under 2 years  ask a doctor

Do Not Use (Do not use)
  • if you are presently taking mineral oil, unless told to do so by a doctor
Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • ach softgel contains: sodium 7mg 
  • store at 15° to 30°C (59° to 86°F)
  • protect from moisture
Package Labeling:

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain 
  • nausea 
  • vomiting 
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:09.386904 · Updated: 2026-03-14T23:01:35.007581